AstraZeneca Calquence Muaj Kev Soj Ntsuam Siab Ntxiv Hauv Kev Kho Kab Mob Ntshav Qab Zib (CLL) Theem 3!

Tsis ntev los no AstraZeneca tau tshaj tawm tias cov txiaj ntsig zoo tau los ntawm lub taub hau-rau-taub hau ELEVATE-RR Ntu 3 kev sim siab pom tau tias nyob rau cov neeg muaj mob loj cov neeg mob ntshav qab zib mob qog ntshav (CLL) uas yav tas los tau txais kev kho mob, nws cov tshuaj tiv thaiv anticancer Calquence Piv nrog AbbVie / J& J Imbruvica (ibrutinib), (acalabrutinib) tsis muaj qhov ua tsis tau zoo yog hais txog kev muaj kev vam meej-tsis muaj txoj sia nyob (PFS) thiab tau mus txog lub hauv paus kev kawm kawg.

Ib qho ntxiv, qhov kev sim tau mus txog qhov tseem ceeb thib ob qhov kawg ntawm kev nyab xeeb: piv nrog Imbruvica kev kho mob pab pawg, qhov xwm txheej ntawm atrial fibrillation hauv Calquence kho pawg tau tshawb pom tsawg dua. Atrial fibrillation yog lub plawv dhia tsis xwm yeem uas tuaj yeem ua rau muaj kev pheej hmoo mob hlab ntsha tawg, plawv nres, thiab lwm yam mob ntsig txog lub plawv. Cov qhab nia ntsuas ntxiv tau pom tias tsis muaj qhov sib txawv ntawm kev sib kis ntawm qib 3 lossis siab dua lossis Richter hloov dua siab tshiab. Lub zuag qhia tag nrho cov ciaj sia qhia ib txoj kev piav qhia uas muaj tswv yim zoo. Feem ntau, kev nyab xeeb thiab thev taus ntawm Calquence yog xwm yeem nrog cov xwm txheej hauv qhov dav dua Calquence kev npaj kho mob.

Nws tsim nyog teev tias ELEVATE-RR yog thawj theem III sim sib piv ob Bruton tyrosine kinase (BTK) inhibitors hauv kev kho mob ntawm CLL cov neeg mob. CLL yog hom leukemia feem ntau muaj rau cov neeg laus. Cov neeg mob kuaj mob uas muaj feem yuav kis tau tus mob CLL yuav muaj kev ploj mus sai. Calquence yog lub cim tshiab ntawm kev xaiv BTK inhibitors, thiab Imbruvica yog lub ntiaj teb' s thawj BTK inhibitor ntawm kev ua lag luam.

ELEVATE-RR yog kev xaiv ntau yam, ntau qhov chaw, qhib-daim ntawv lo khoom theem 3 tsis muaj qhov ua tsis tau zoo. Cov neeg mob sau npe tau raug kho yav dhau los cov neeg mob CLL uas muaj cov yam ntxwv tsis zoo (17p tshem tawm thiab / lossis 11q cais tawm). Hauv txoj kev tshawb no, 533 tus neeg mob tau txais kev kho (1: 1) faib ua 2 pab. Ib pab pawg tau txais Calquence kho (100 mg hais lus, 2 zaug hauv ib hnub), thiab lwm pab pawg tau txais Imbruvica (420 mg hais lus, ib hnub ib zaug) kom txog thaum tus kab mob loj zuj zus lossis tsis paub yuav muaj cov tshuaj lom. Thawj qhov kawg ntawm kev sim yog PFS (tsis yog-tsis muaj qhov tsis muaj qab hau, sim tom qab 250 qhov xwm txheej) raug ntsuas los ntawm pawg kws tshuaj ntsuam xyuas kev ywj pheej. Cov theem ob kawg suav nrog qhov tshwm sim ntawm atrial fibrillation, qhov tshwm sim ntawm qib 3 lossis siab dua qhov mob tshwm sim los ntawm kev kho mob, qhov xwm txheej ntawm Richter hloov (ib qho mob uas CLL hloov mus rau kev mob qog ua hlav), thiab tag nrho cov muaj sia nyob.

Cov ntaub ntawv los ntawm kev sim yuav tshaj tawm hauv kev sib tham txog kev kho mob tom qab thiab qhia tawm rau cov chaw tswj hwm.

José Baselga, Tus Lwm Thawj Coj ntawm Oncology Kev Tshawb Fawb thiab Kev Loj Hlob ntawm AstraZeneca, tau hais tias: "Tom qab ntau tshaj 40 lub hlis ntawm kev rov qab soj ntsuam, cov txiaj ntsig niaj hnub no tau lees tias Calquence tau qhia muaj kev nyab xeeb zoo dua ntawm atrial fibrillation nrog kev ua tsis tau zoo. Tag nrho cov ntaub ntawv muaj tseeb peb muaj kev ntseeg siab hauv Calquence txoj kev xa rov qab thiab cov yam ntxwv pheej hmoo."

Calquence tau pom zoo los ntawm Asmeskas FDA rau kev ua lag luam nrawm nrawm rau Lub Kaum Hlis 2017. Qhov ntsuas muaj xws li: (1) Rau cov neeg laus cov neeg mob uas rov mob lossis tso ntshav rov qab mob hlwb (MCL) uas yav tas los tau txais tsawg kawg ib txoj kev kho; (2) Siv Rau Kev kho mob rau cov neeg mob laus uas mob lymphocytic leukemia (CLL) lossis cov qe ntshav ntawm tes me me (SLL).

Calquence' s lub tshuaj ua haujlwm sib xyaw ua ke yog acalabrutinib, uas yog lwm tiam tom ntej, xaiv zoo, muaj zog, covalent Bruton tyrosine kinase (BTK) inhibitor uas tiv thaiv BTK los ntawm kev khi ruaj khov. BTK yog kev tswj hwm qhov tseem ceeb ntawm B cell receptor (BCR) cov paib piav qhia. Nws tau dav dav hauv ntau hom kev hematological malignancies thiab koom nrog txoj kev loj hlob, thauj, chemotaxis thiab kev nplaum ntawm B hlwb. Yog li, nws yog ib qho tseem ceeb rau kev kho mob hematological malignancies. Phiajzeb. Hauv qhov kev tshawb fawb preclinical, acalabrutinib qhia tau tias muaj qhov cuam tshuam tsawg kawg-phiaj yam.

Tam sim no, Calquence raug tsim rau ntau hom B-cell ntshav qog nqaij hlav, nrog rau CLL, MCL, diffuse loj B-cell lymphoma (DLBCL), Waldenstrom macroglobulinemia (WM), follicular lymphoma (FL), Ntau yam myeloma thiab lwm yam mob hematological malignancies.

Calquence' s mechanism ntawm kev ua yog tib yam li AbbVie / J& J' s blockbuster ntshav mob qog ntshav Imbruvica (ibrutinib), uas yog thawj BTK inhibitor pom zoo thoob ntiaj teb. Txij li thaum nws pom zoo thawj zaug thaum Lub Kaum Ib Hlis 2013, Imbruvica tau pom zoo rau ntau npaum li ntawm 11 kev kho mob hauv 6 thaj chaw muaj kabmob, thiab kev muag khoom thoob ntiaj teb tau nce siab zuj zus. Lub Rau Hli xyoo tas los, lub koom haum kev tshawb fawb txog kev lag luam hauv kev lag luam EvaluatePharma tso tawm cov lus kwv yees hais tias nrog cov kev lag luam txuas ntxiv mus thiab qhov taw qhia nce ntxiv, Imbruvica' s muag hauv 2026 yuav txog 10.722 billion daus las US, ua lub ntiaj teb' s thib tsib cov tshuaj zoo tshaj plaws.